Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone

This study is currently recruiting participants.
Verified May 2012 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor:
Information provided by (Responsible Party):
Emiliano Tognoli, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier:
NCT01594047
First received: May 5, 2012
Last updated: May 15, 2012
Last verified: May 2012

May 5, 2012
May 15, 2012
December 2009
June 2012   (final data collection date for primary outcome measure)
the extent of hyperalgesia area proximal to surgical wound [ Time Frame: 24 and 48 hours after surgery ] [ Designated as safety issue: No ]

Hyperalgesia is determined by stimulating with a won Fray hair N°16 along three line at right angle to the top, middle and bottom sides of the surgical incision. Each line start from the edge of abdomen to the surgical incision.

Stimulation continue from edge toward the surgical incision untill the patients reported a worsening in sensation The distance from the incision to where sensation change was measured and the three assessments was calculated

Same as current
Complete list of historical versions of study NCT01594047 on ClinicalTrials.gov Archive Site
  • pain intensity [ Time Frame: 24 and 40 hours after surgery ] [ Designated as safety issue: No ]
    A Numerical rating scale is used to quantifie pain intensity
  • opioids related adverse events [ Time Frame: 24 and 48 hours after surgery ] [ Designated as safety issue: No ]
    post operative nause and vomiting, respiratory depression.
Same as current
Not Provided
Not Provided
 
Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone
Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone

Background: In perioperative period inhibition of N-Methyl-D-Aspartate receptor prevents opioid-induced hyperalgesia and reduce postoperative opioid requirement after abdominal surgery. Methadone is both a µ-opioid receptor agonist like Morphine and a N-Methyl-D-Aspartate antagonist. Study Aim. To evaluate the efficacy of intraoperative Ketamine and postoperative Methadone analgesia in preventing opioid-induced hyperalgesia after abdominal surgery.

not desired

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Post Operative Pain
  • Hyperalgesia
  • Drug: ketamine infusion
    Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery
    Other Name: hyperalgesia-blocker
  • Drug: Methadone PCA
    Methadone administered by a PCA system (dose 2 mg, lock-out 12min.)
    Other Name: hyperalgesia-blocker
  • No Intervention: zero/morphine
    Patient received a standard balance anaesthesia and morphine for post operative pain.
  • Experimental: ketamine/morphine
    patients received a balance anaesthesia supplemented by low dose of ketamine and Morphine by PCA device for postoperative pain
    Intervention: Drug: ketamine infusion
  • Experimental: zero/metadone
    patients received a standard balance anaesthesia and methadone by PCA device for postoperative pain
    Intervention: Drug: Methadone PCA
  • Experimental: ketamine/methadone
    Patients received a balance anaesthesia supplemented with low dose of ketamine and Methadone by PCA device for postoperative pain
    Interventions:
    • Drug: ketamine infusion
    • Drug: Methadone PCA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
96
August 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients undergoing open colo-rectal surgery

Exclusion Criteria:

  • ASA status more than II, history of chronic pain, ischemic heart disease or chronic pulmonary disease, allergy to any drugs used in the protocol. Body Max Index more than 35.
Both
18 Years to 75 Years
No
Contact: Emiliano Tognoli 02/23902176 Emiliano.Tognoli@istitutotumori.mi.it
Contact: Langer Martin 02/23902282 Martin.Langer@istitutotumori.mi.it
Italy
 
NCT01594047
metadone
No
Emiliano Tognoli, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Not Provided
Principal Investigator: Emiliano Tognoli Fondazione IRCCS Istituto Nazionale dei Tumori
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP